Hycamtin 1mg Capsules
WARNING: Low blood cell counts may happen with this drug. Low blood cell counts may raise the chance of needing a blood transfusion or getting an infection or bleeding. If you have questions, talk with the doctor.Have your blood work and other lab tests checked as you have been told by your doctor. @ COMMON USES: It is used to treat cancer.
Drug Class
Antineoplastic Agent
Pharmacologic Class
Topoisomerase I Inhibitor
Pregnancy Category
Category D
FDA Approved
Oct 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
Topotecan is a chemotherapy medicine used to treat certain types of cancer, like small cell lung cancer. It works by stopping cancer cells from growing and dividing, which helps to shrink tumors and slow down the disease.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. When handling this medication, take special precautions. Consult your doctor or pharmacist for guidance on how to handle it safely.
You can take this medication with or without food. Swallow the capsules whole - do not chew, open, or crush them. Your dose may consist of two or more different strengths and colors of capsules. If you vomit after taking a dose, do not take an additional dose. Instead, take your next dose at the scheduled time.
If a capsule is accidentally opened or broken, avoid touching the contents. If you do come into contact with the contents or get them in your eyes, wash your hands or eyes immediately.
Storing and Disposing of Your Medication
Store your medication in the refrigerator, but do not freeze it. Keep it in its original container to protect it from light.
What to Do If You Miss a Dose
If you miss a dose, skip it and take your next dose at the usual time. Do not take two doses at the same time or take extra doses to make up for the missed one.
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. When handling this medication, take special precautions. Consult your doctor or pharmacist for guidance on how to handle it safely.
You can take this medication with or without food. Swallow the capsules whole - do not chew, open, or crush them. Your dose may consist of two or more different strengths and colors of capsules. If you vomit after taking a dose, do not take an additional dose. Instead, take your next dose at the scheduled time.
If a capsule is accidentally opened or broken, avoid touching the contents. If you do come into contact with the contents or get them in your eyes, wash your hands or eyes immediately.
Storing and Disposing of Your Medication
Store your medication in the refrigerator, but do not freeze it. Keep it in its original container to protect it from light.
What to Do If You Miss a Dose
If you miss a dose, skip it and take your next dose at the usual time. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Avoid contact with people who are sick or have infections, as your immune system will be weakened.
- Practice good hand hygiene (wash hands frequently).
- Report any signs of infection (fever, chills, sore throat) immediately.
- Avoid activities that could cause cuts or bruises.
- Maintain good oral hygiene to prevent mouth sores.
- Stay well-hydrated and follow dietary advice from your healthcare team to manage nausea/diarrhea.
- Use effective contraception during treatment and for a period after, as this drug can harm a fetus.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
2.3 mg/m² orally once daily for 5 consecutive days, repeated every 21 days.
Condition-Specific Dosing:
Small Cell Lung Cancer (SCLC):
2.3 mg/m² orally once daily for 5 consecutive days, repeated every 21 days. Treatment should be delayed if severe neutropenia or thrombocytopenia occurs.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment for CrCl > 60 mL/min.
Moderate:
For CrCl 30-59 mL/min, reduce dose to 0.7 mg/m² orally once daily for 5 consecutive days, repeated every 21 days.
Severe:
Not recommended for CrCl < 30 mL/min due to insufficient data and potential for increased toxicity.
Dialysis:
Not recommended for patients on dialysis.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended for mild to moderate hepatic impairment (bilirubin 1.5-3.0 mg/dL).
Moderate:
No specific dose adjustment recommended for mild to moderate hepatic impairment (bilirubin 1.5-3.0 mg/dL).
Severe:
Not studied in patients with severe hepatic impairment (bilirubin > 3.0 mg/dL); use with caution.
Pharmacology
Mechanism of Action
Topotecan is a topoisomerase I inhibitor. It binds to the topoisomerase I-DNA complex, preventing religation of the DNA single-strand breaks. This leads to accumulation of DNA single-strand breaks, which are converted to irreversible double-strand breaks during DNA replication, ultimately leading to cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 40% (range 19-60%)
Tmax:
1-2 hours
FoodEffect:
Food does not significantly affect the absorption of topotecan capsules.
Distribution:
Vd:
Approximately 60 L/m²
ProteinBinding:
Approximately 35%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 3 hours (lactone form)
Clearance:
Approximately 67 L/h/m²
ExcretionRoute:
Renal (30-50%) and biliary/fecal (20-30%)
Unchanged:
Approximately 30-50% excreted unchanged in urine
Pharmacodynamics
OnsetOfAction:
Not precisely defined for antineoplastic effect; cellular effects begin rapidly after exposure.
PeakEffect:
Not precisely defined for antineoplastic effect; peak plasma concentrations occur within 1-2 hours.
DurationOfAction:
Related to drug exposure and cellular damage; effects persist beyond plasma half-life due to DNA damage.
Safety & Warnings
BLACK BOX WARNING
Topotecan can cause severe myelosuppression, including neutropenia, thrombocytopenia, and anemia, resulting in infection, bleeding, or symptomatic anemia. Myelosuppression is dose-limiting. Monitor complete blood counts frequently. Do not administer Hycamtin capsules to patients with a baseline neutrophil count of less than 1,500 cells/mm³ or a platelet count of less than 100,000 cells/mm³.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal
Signs of bleeding: vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, gum bleeding, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding
Severe diarrhea or diarrhea accompanied by stomach cramps, nausea, vomiting, fever, or fluid loss
Lung problems: shortness of breath, difficulty breathing, new or worsening cough, or fever (these can be life-threatening)
Severe bowel problems: stomach pain (with or without fever), tender stomach, or diarrhea (these can be life-threatening and may occur as early as the first day of symptoms)
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Feeling tired or weak
Hair loss
* Diarrhea, vomiting, nausea, and decreased appetite (these are common side effects, but your doctor can help you manage them)
If any of these side effects bother you, don't improve, or are severe, contact your doctor for guidance.
Reporting Side Effects
For more information about side effects or to report any concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal
Signs of bleeding: vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, gum bleeding, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding
Severe diarrhea or diarrhea accompanied by stomach cramps, nausea, vomiting, fever, or fluid loss
Lung problems: shortness of breath, difficulty breathing, new or worsening cough, or fever (these can be life-threatening)
Severe bowel problems: stomach pain (with or without fever), tender stomach, or diarrhea (these can be life-threatening and may occur as early as the first day of symptoms)
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Feeling tired or weak
Hair loss
* Diarrhea, vomiting, nausea, and decreased appetite (these are common side effects, but your doctor can help you manage them)
If any of these side effects bother you, don't improve, or are severe, contact your doctor for guidance.
Reporting Side Effects
For more information about side effects or to report any concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Fever (100.4°F or 38°C or higher) or chills
- Unusual bleeding or bruising (e.g., nosebleeds, bleeding gums, black or tarry stools)
- Severe or persistent diarrhea, nausea, or vomiting
- Severe fatigue or weakness
- Signs of allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the symptoms you experienced.
Certain health conditions, such as a low white blood cell count, low platelet count, or low red blood cell count.
* If you are breastfeeding, as you should not breastfeed while taking this medication and for 1 week after your last dose.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the symptoms you experienced.
Certain health conditions, such as a low white blood cell count, low platelet count, or low red blood cell count.
* If you are breastfeeding, as you should not breastfeed while taking this medication and for 1 week after your last dose.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Before operating a vehicle or engaging in any activity that requires your full attention, wait until you understand how this medication affects you. Be aware that you may have a higher risk of developing infections, some of which can be severe or even life-threatening. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or the flu.
You may experience an increased tendency to bleed easily while taking this medication. Therefore, it is crucial to exercise caution and avoid injuries. To reduce the risk of bleeding, use a soft-bristled toothbrush and an electric razor for shaving.
The oral form of this medication can cause severe diarrhea, which in some cases may be life-threatening and require hospitalization. If you experience diarrhea, consult your doctor promptly. Do not attempt to treat diarrhea without first consulting your doctor.
Before receiving any vaccinations, discuss the potential risks and benefits with your doctor, as certain vaccines may not be effective or may increase the risk of infection when taken with this medication.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
This medication may affect fertility, potentially leading to difficulties in becoming pregnant or fathering a child. If you plan to conceive, discuss the potential risks and benefits with your doctor before initiating treatment.
This medication can cause harm to an unborn baby. To confirm that you are not pregnant, a pregnancy test will be conducted before you start taking this medication. If you may become pregnant, use effective birth control methods while taking this medication and for 6 months after your last dose, unless otherwise advised by your doctor. It is essential to understand the duration for which you need to use birth control. If you become pregnant, notify your doctor immediately.
If your partner may become pregnant, you may need to use birth control while taking this medication and for a certain period after the last dose. Consult your doctor to discuss the necessary precautions and recommendations.
Before operating a vehicle or engaging in any activity that requires your full attention, wait until you understand how this medication affects you. Be aware that you may have a higher risk of developing infections, some of which can be severe or even life-threatening. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or the flu.
You may experience an increased tendency to bleed easily while taking this medication. Therefore, it is crucial to exercise caution and avoid injuries. To reduce the risk of bleeding, use a soft-bristled toothbrush and an electric razor for shaving.
The oral form of this medication can cause severe diarrhea, which in some cases may be life-threatening and require hospitalization. If you experience diarrhea, consult your doctor promptly. Do not attempt to treat diarrhea without first consulting your doctor.
Before receiving any vaccinations, discuss the potential risks and benefits with your doctor, as certain vaccines may not be effective or may increase the risk of infection when taken with this medication.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
This medication may affect fertility, potentially leading to difficulties in becoming pregnant or fathering a child. If you plan to conceive, discuss the potential risks and benefits with your doctor before initiating treatment.
This medication can cause harm to an unborn baby. To confirm that you are not pregnant, a pregnancy test will be conducted before you start taking this medication. If you may become pregnant, use effective birth control methods while taking this medication and for 6 months after your last dose, unless otherwise advised by your doctor. It is essential to understand the duration for which you need to use birth control. If you become pregnant, notify your doctor immediately.
If your partner may become pregnant, you may need to use birth control while taking this medication and for a certain period after the last dose. Consult your doctor to discuss the necessary precautions and recommendations.
Overdose Information
Overdose Symptoms:
- Severe myelosuppression (very low white blood cell, red blood cell, and platelet counts)
- Severe gastrointestinal toxicity (e.g., severe diarrhea, mucositis)
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.
Drug Interactions
Major Interactions
- Myelosuppressive agents (e.g., other chemotherapy, radiation therapy): Increased risk of severe myelosuppression.
- G-CSF (Granulocyte Colony-Stimulating Factor): Concurrent use may prolong the duration of neutropenia.
Moderate Interactions
- Strong CYP3A4 inhibitors/inducers: Potential for altered topotecan exposure, though clinical significance for oral form is less established than for IV.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential and platelet count
Rationale: To establish baseline hematologic parameters and assess for pre-existing myelosuppression.
Timing: Prior to initiation of treatment.
Renal function tests (Serum Creatinine, CrCl)
Rationale: To assess kidney function, as dose adjustments are required for renal impairment.
Timing: Prior to initiation of treatment.
Hepatic function tests (Bilirubin, AST, ALT)
Rationale: To assess liver function, as severe impairment may warrant caution.
Timing: Prior to initiation of treatment.
Routine Monitoring
Complete Blood Count (CBC) with differential and platelet count
Frequency: Weekly or prior to each cycle and periodically during treatment.
Target: Absolute Neutrophil Count (ANC) ≥ 1,500 cells/mm³, Platelets ≥ 100,000 cells/mm³ for next cycle.
Action Threshold: Delay treatment if ANC < 1,500 cells/mm³ or platelets < 100,000 cells/mm³; consider dose reduction for subsequent cycles if severe myelosuppression occurs.
Renal function tests
Frequency: Periodically during treatment, especially if renal function changes are suspected.
Target: Not applicable (monitor for decline)
Action Threshold: Adjust dose if CrCl falls to 30-59 mL/min; discontinue if CrCl < 30 mL/min.
Symptom Monitoring
- Signs of infection (fever, chills, sore throat)
- Unusual bleeding or bruising
- Severe or persistent diarrhea
- Nausea, vomiting, abdominal pain
- Fatigue, weakness
- Signs of allergic reaction (rash, itching, swelling)
Special Patient Groups
Pregnancy
Topotecan can cause fetal harm when administered to a pregnant woman. It is classified as Pregnancy Category D. Women of childbearing potential should be advised to avoid becoming pregnant during therapy.
Trimester-Specific Risks:
First Trimester:
High risk of major birth defects and fetal loss due to rapid cell division during organogenesis.
Second Trimester:
Risk of fetal growth restriction, myelosuppression, and other adverse effects.
Third Trimester:
Risk of myelosuppression in the neonate and other adverse effects.
Lactation
It is not known whether topotecan is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, breastfeeding is contraindicated during topotecan therapy.
Infant Risk:
High risk of serious adverse effects, including myelosuppression, in the infant.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.
Geriatric Use
No overall differences in effectiveness or safety were observed between elderly (≥65 years) and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Monitor renal function closely, as elderly patients are more likely to have decreased renal function.
Clinical Information
Clinical Pearls
- Oral topotecan is often used as a convenient alternative to IV topotecan for patients with relapsed small cell lung cancer.
- The primary dose-limiting toxicity is myelosuppression, particularly neutropenia. Close monitoring of CBC is crucial.
- Patients should be educated on the signs and symptoms of infection and bleeding and instructed to report them immediately.
- Antiemetics and antidiarrheals should be readily available to manage gastrointestinal side effects.
- Ensure patients understand the 5-day dosing schedule and the 21-day cycle repetition.
- Hydration is important to prevent and manage potential renal toxicity, although topotecan is primarily renally excreted, direct nephrotoxicity is not a major concern.
Alternative Therapies
- Other topoisomerase I inhibitors (e.g., Irinotecan)
- Other chemotherapy agents used in SCLC (e.g., Etoposide, Cisplatin, Carboplatin, Lurbinectedin)
- Immunotherapy agents (e.g., Pembrolizumab, Nivolumab, Atezolizumab, Durvalumab) for SCLC
Cost & Coverage
Average Cost:
Varies widely, typically several thousand USD per cycle
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to high co-pays or co-insurance)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.